BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS TRABECULAR METAL TIBIAL TRAY

    MDR report key: 2030621 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00665
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2010
    Report Date
    February 23, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: HOLOGRAPHIC INSPECTION DID NOT REVEAL ANY DISBONDED AREAS. BASED ON THE INVESTIGATION, IT APPEARS AS THOUGH THE BOND BETWEEN THE TM PAD AND THE TIVANIUM SUBSTRATE WAS SUFFICIENT. BASED ON THE INFORMATION AVAILABLE, THE REVISION APPEARS TO BE FOR PAIN AND LOOSENING THAT WERE CAUSED BY THE PATIENT'S FALL. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS / ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED BY EITHER METHOD. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR LOOSENING AND PAIN AFTER FALLING OFF HIS BIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS TRABECULAR METAL TIBIAL TRAY MBH ZIMMER, INC. 61033723

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention